EP3071286A4 - Systems, devices and methods for the creation of a therapeutic restriction in the gastrointestinal tract - Google Patents

Systems, devices and methods for the creation of a therapeutic restriction in the gastrointestinal tract Download PDF

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Publication number
EP3071286A4
EP3071286A4 EP14864511.2A EP14864511A EP3071286A4 EP 3071286 A4 EP3071286 A4 EP 3071286A4 EP 14864511 A EP14864511 A EP 14864511A EP 3071286 A4 EP3071286 A4 EP 3071286A4
Authority
EP
European Patent Office
Prior art keywords
creation
systems
methods
devices
gastrointestinal tract
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP14864511.2A
Other languages
German (de)
French (fr)
Other versions
EP3071286A1 (en
EP3071286B1 (en
Inventor
Harith RAJAGOPALAN
Jay Caplan
R. Maxwell Flaherty
J. Christopher Flaherty
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Fractyl Health Inc
Original Assignee
Fractyl Laboratories Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from PCT/US2014/040957 external-priority patent/WO2014197632A2/en
Priority claimed from US14/470,503 external-priority patent/US10349998B2/en
Priority claimed from PCT/US2014/055514 external-priority patent/WO2015038973A1/en
Priority claimed from US14/515,324 external-priority patent/US20150045825A1/en
Application filed by Fractyl Laboratories Inc filed Critical Fractyl Laboratories Inc
Publication of EP3071286A1 publication Critical patent/EP3071286A1/en
Publication of EP3071286A4 publication Critical patent/EP3071286A4/en
Application granted granted Critical
Publication of EP3071286B1 publication Critical patent/EP3071286B1/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0082—Catheter tip comprising a tool
    • A61M25/0084—Catheter tip comprising a tool being one or more injection needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F5/0076—Implantable devices or invasive measures preventing normal digestion, e.g. Bariatric or gastric sleeves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/726—Glycosaminoglycans, i.e. mucopolysaccharides
    • A61K31/728—Hyaluronic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/42—Phosphorus; Compounds thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/33—Fibroblasts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/35—Fat tissue; Adipocytes; Stromal cells; Connective tissues
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04—Macromolecular materials
    • A61L31/043—Proteins; Polypeptides; Degradation products thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04—Macromolecular materials
    • A61L31/048—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04—Macromolecular materials
    • A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/145—Hydrogels or hydrocolloids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/16—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0082—Catheter tip comprising a tool
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F2005/0016—Implantable devices or invasive measures comprising measuring means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0082—Catheter tip comprising a tool
    • A61M25/0084—Catheter tip comprising a tool being one or more injection needles
    • A61M2025/0089—Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0082—Catheter tip comprising a tool
    • A61M2025/0096—Catheter tip comprising a tool being laterally outward extensions or tools, e.g. hooks or fibres
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/20—Applying electric currents by contact electrodes continuous direct currents
    • A61N1/30—Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
    • A61N1/303—Constructional details
    • A61N1/306—Arrangements where at least part of the apparatus is introduced into the body

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Epidemiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Cell Biology (AREA)
  • Surgery (AREA)
  • Pulmonology (AREA)
  • Biophysics (AREA)
  • Virology (AREA)
  • Immunology (AREA)
  • Developmental Biology & Embryology (AREA)
  • Biotechnology (AREA)
  • Zoology (AREA)
  • Obesity (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Nursing (AREA)
  • Child & Adolescent Psychology (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Surgical Instruments (AREA)
  • Prostheses (AREA)
EP14864511.2A 2013-11-22 2014-11-21 Systems for the creation of a therapeutic restriction in the gastrointestinal tract Active EP3071286B1 (en)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US201361907808P 2013-11-22 2013-11-22
PCT/US2014/040957 WO2014197632A2 (en) 2013-06-04 2014-06-04 Methods, systems and devices for reducing the luminal surface area of the gastrointestinal tract
US14/470,503 US10349998B2 (en) 2012-02-27 2014-08-27 Heat ablation systems, devices and methods for the treatment of tissue
PCT/US2014/055514 WO2015038973A1 (en) 2013-09-12 2014-09-12 Systems, methods and devices for treatment of target tissue
US14/515,324 US20150045825A1 (en) 2012-04-19 2014-10-15 Tissue expansion devices, systems and methods
PCT/US2014/066829 WO2015077571A1 (en) 2013-11-22 2014-11-21 Systems, devices and methods for the creation of a therapeutic restriction in the gastrointestinal tract

Publications (3)

Publication Number Publication Date
EP3071286A1 EP3071286A1 (en) 2016-09-28
EP3071286A4 true EP3071286A4 (en) 2017-09-06
EP3071286B1 EP3071286B1 (en) 2024-01-03

Family

ID=53180187

Family Applications (1)

Application Number Title Priority Date Filing Date
EP14864511.2A Active EP3071286B1 (en) 2013-11-22 2014-11-21 Systems for the creation of a therapeutic restriction in the gastrointestinal tract

Country Status (8)

Country Link
US (4) US10232143B2 (en)
EP (1) EP3071286B1 (en)
JP (4) JP6603660B2 (en)
KR (1) KR102284469B1 (en)
AU (2) AU2014352874B2 (en)
CA (1) CA2930612A1 (en)
IL (1) IL245540B (en)
WO (1) WO2015077571A1 (en)

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US10064697B2 (en) 2008-10-06 2018-09-04 Santa Anna Tech Llc Vapor based ablation system for treating various indications
US10695126B2 (en) 2008-10-06 2020-06-30 Santa Anna Tech Llc Catheter with a double balloon structure to generate and apply a heated ablative zone to tissue
CN103582463B (en) 2011-01-19 2018-02-13 弗拉克泰尔实验室公司 Apparatus and method for tissue treatment
WO2013130655A1 (en) 2012-02-27 2013-09-06 Fractyl Laboratories, Inc. Heat ablation systems, devices and methods for the treatment of tissue
WO2015077571A1 (en) 2013-11-22 2015-05-28 Fractyl Laboratories, Inc. Systems, devices and methods for the creation of a therapeutic restriction in the gastrointestinal tract
EP2838598B1 (en) 2012-04-19 2020-01-15 Fractyl Laboratories, Inc. Tissue expansion devices
EP2879605A4 (en) 2012-07-30 2016-04-06 Fractyl Lab Inc Electrical energy ablation systems, devices and methods for the treatment of tissue
EP2882362B1 (en) 2012-08-09 2024-01-03 Fractyl Health, Inc. Ablation systems, devices and methods for the treatment of tissue
EP2903626A4 (en) 2012-10-05 2016-10-19 Fractyl Lab Inc Methods, systems and devices for performing multiple treatments on a patient
EP2945556A4 (en) 2013-01-17 2016-08-31 Virender K Sharma Method and apparatus for tissue ablation
EP3003461B1 (en) 2013-06-04 2019-05-01 Fractyl Laboratories, Inc. Systems and devices for reducing the luminal surface area of the gastrointestinal tract
EP3043732B1 (en) 2013-09-12 2021-04-07 Fractyl Laboratories, Inc. Systems and devices for treatment of target tissue
US10959774B2 (en) 2014-03-24 2021-03-30 Fractyl Laboratories, Inc. Injectate delivery devices, systems and methods
US11185367B2 (en) 2014-07-16 2021-11-30 Fractyl Health, Inc. Methods and systems for treating diabetes and related diseases and disorders
US9844641B2 (en) 2014-07-16 2017-12-19 Fractyl Laboratories, Inc. Systems, devices and methods for performing medical procedures in the intestine
WO2016011269A1 (en) 2014-07-16 2016-01-21 Fractyl Laboratories, Inc. Methods and systems for treating diabetes and related diseases and disorders
US10213245B2 (en) 2015-03-10 2019-02-26 PAVmed Inc. Continuous flow balloon catheter systems and methods of use
US11331140B2 (en) 2016-05-19 2022-05-17 Aqua Heart, Inc. Heated vapor ablation systems and methods for treating cardiac conditions
KR101834784B1 (en) * 2016-05-20 2018-04-19 (주)에스엠허스 Pre-jellied the tube holder for medical treatment
WO2019207705A1 (en) 2018-04-26 2019-10-31 オリンパス株式会社 Treatment system and expansion device
AU2019279011A1 (en) 2018-06-01 2021-01-07 Santa Anna Tech Llc Multi-stage vapor-based ablation treatment methods and vapor generation and delivery systems

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WO2013159066A1 (en) * 2012-04-19 2013-10-24 Fractyl Laboratories, Inc. Tissue expansion devices, system and methods

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